Drug factory · FDA FEI 1010370

USpharma Ltd

13900 N.W. 57 Court, Miami Lake, FL, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 3, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

7 drug inspections on record since 2010: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Nitroglycerin	Makes it	Dr. Reddy's Laboratories Inc., Ingenus Pharmaceuticals, LLC	43598-893, 43598-894, 43598-895 +7

Ended	Result	Program	Problems noted
Sep 3, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	2
Feb 16, 2023	No problems found	Drug Quality Assurance	—
Jun 23, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	3
Feb 3, 2015	No problems found	Drug Quality Assurance	—
Apr 2, 2012	No problems found	Postmarket Surv. and Epidemiology	—
Apr 2, 2012	No problems found	Drug Quality Assurance	—
May 11, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	2

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Test methods 21 CFR 211.165(e)
The sensitivity of test methods have not been established.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.

Representative Samples 21 CFR 211.84(b)
Representative samples are not taken of each shipment of each lot of components for testing or examination.
Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Registered with FDA for: analysis; manufacture; pack.